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Trial record 64 of 467 for:    TRAMADOL

Comparison of Metoprolol and Tramadol With Remifentanil in Endoscopic Sinus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02484859
Recruitment Status : Completed
First Posted : June 30, 2015
Results First Posted : September 10, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Başar Erdivanlı, Rize Üniversitesi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Condition Nasal Polyps
Interventions Drug: Remifentanil
Drug: Tramadol
Drug: Metoprolol
Enrollment 88
Recruitment Details Recruitment period started at 27.06.2015. Recruitment was performed by an anaesthesiologist at the outpatient polyclinic for anaesthesiology.
Pre-assignment Details A total of 105 patients were evaluated. Three patients declined to participate in the study. Eleven patients did not meet inclusion criteria. On 29 December 2015, we reached the target number of patients (88). Since patients were matched for severity of sinonasal disease, we evaluated three more patients anticipating possible dropouts.
Arm/Group Title Remifentanil Tramadol + Metoprolol
Hide Arm/Group Description Following an intravenous bolus dose of 0.5 µg/kg remifentanil administered just before the induction of anaesthesia, patients will receive an intravenous infusion of remifentanil at a dose of 0.25-0.5 µg/kg/min throughout the surgery. The rate of infusion will be adjusted to maintain a mean blood pressure within %70-80 of the baseline value. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated. Just before the induction of anaesthesia, an intravenous infusion of 1 mg/kg of tramadol in 100 ml isotonic fluid will be started. The infusion will be completed in 30 minutes using a perfusor. Additionally, following the administration of the neuromuscular blocking agent, 0.1 mg/kg of intravenous metoprolol will be administered within 5 minutes.
Period Title: Overall Study
Started 44 44
Completed 44 44
Not Completed 0 0
Arm/Group Title Remifentanil Tramadol + Metoprolol Total
Hide Arm/Group Description Following an intravenous bolus dose of 0.5 µg/kg remifentanil administered just before the induction of anaesthesia, patients will receive an intravenous infusion of remifentanil at a dose of 0.25-0.5 µg/kg/min throughout the surgery. The rate of infusion will be adjusted to maintain a mean blood pressure within %70-80 of the baseline value. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated. Just before the induction of anaesthesia, an intravenous infusion of 1 mg/kg of tramadol in 100 ml isotonic fluid will be started. The infusion will be completed in 30 minutes using a perfusor. Additionally, following the administration of the neuromuscular blocking agent, 0.1 mg/kg of intravenous metoprolol will be administered within 5 minutes. Total of all reporting groups
Overall Number of Baseline Participants 44 44 88
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 44 participants 88 participants
37.8  (10.1) 39.3  (10.6) 38.6  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
Female
16
  36.4%
12
  27.3%
28
  31.8%
Male
28
  63.6%
32
  72.7%
60
  68.2%
American Society of Anesthesiologists physical status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
1
24
  54.5%
25
  56.8%
49
  55.7%
2
20
  45.5%
19
  43.2%
39
  44.3%
[1]
Measure Description:

American Society of Anesthesiologists (ASA) physical status 1 denotes a normal healthy patient. This means a healthy, non-smoking person who exhibits no or minimal alcohol use.

ASA physical status 2 denotes a patient with mild systemic disease (mild diseases only without substantive functional limitations). Examples include (but not limited to): current smoker, social alcohol drinker, pregnancy, obesity (30 < body mass index < 40), well-controlled diabetes mellitus/hypertension, mild lung disease.

Lund-Mackay score   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 44 participants 44 participants 88 participants
12
(8.75 to 15)
10
(6 to 14)
11
(7 to 14.25)
[1]
Measure Description: Various staging systems have been proposed for use in chronic rhinosinusitis. Many studies use the Lund-Mackay scale to evaluate radiographic images. This scale grades the right and left sides independently, looking at the maxillary, anterior ethmoids, posterior ethmoids, sphenoid, and frontal sinuses, as well as the ostiomeatal complex. Each sinus is scored a 0 (no abnormality), 1 (partial opacification), or 2 (total opacification), while the ostiomeatal complex is scored either a 0 or 2 (for presence or absence of disease). Scores range from 0-24.
Prothrombin time   [1] 
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 44 participants 44 participants 88 participants
13.1  (0.5) 13.4  (0.6) 13.3  (0.6)
[1]
Measure Description: Prothrombin time is a blood test that measures the time it takes for the liquid portion of the blood to clot. If a person is not taking blood thinning medicines, the normal range is 11 to 13.5 seconds.
Partial thromboplastin time   [1] 
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 44 participants 44 participants 88 participants
30.6  (2.2) 29.7  (2.2) 30.1  (2.3)
[1]
Measure Description: Partial thromboplastin time is a blood test that looks at how long it takes for blood to clot. In general, clotting should occur within 25 to 35 seconds. If the person is taking blood thinners, clotting takes up to two-and-a-half times longer.
International normalized ratio   [1] 
Mean (Standard Deviation)
Unit of measure:  International normalized ratio
Number Analyzed 44 participants 44 participants 88 participants
1.01  (0.07) 1.02  (0.08) 1.01  (0.07)
[1]
Measure Description: Prothrombin time is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot. Prothrombin time is measured in seconds. Most of the time, results are given as what is called international normalized ratio (INR).
Haemoglobin   [1] 
Mean (Standard Deviation)
Unit of measure:  Grams per deciliter
Number Analyzed 44 participants 44 participants 88 participants
14.1  (1.3) 14.2  (1.3) 14.2  (1.3)
[1]
Measure Description:

The haemoglobin test is a blood test that measures how much haemoglobin is in the blood. Haemoglobin is a protein in red blood cells that carries oxygen. Normal results for adults vary, but in general are:

Male: 13.8 to 17.2 grams per deciliter (g/dl) Female: 12.1 to 15.1 g/dl

Platelet count   [1] 
Mean (Standard Deviation)
Unit of measure:  10^3 platelets per microliter
Number Analyzed 44 participants 44 participants 88 participants
236  (69) 242  (69) 239  (69)
[1]
Measure Description: A platelet count is a lab test to measure how many platelets are present in the blood. Platelets are parts of the blood that help the blood clot. The normal number of platelets in the blood is 150 000 to 400 000 platelets per microliter (mcl). Normal value ranges may vary slightly.
1.Primary Outcome
Title Intraoperative Bleeding Score
Hide Description

Intraoperative bleeding score is reported by the surgeon according to Boezaart Surgical Field Grading scale. The scale ranges from 0 to 5. '0' is the best, and '5' is the worst outcome.

The scale construct is:

0 No bleeding.

  1. Slight bleeding, no suction is required.
  2. Slight bleeding, occasional suctioning required.
  3. Slight bleeding, frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.
  4. Moderate bleeding, frequent suctioning required. Bleeding threatens surgical field as soon as suction is removed.
  5. Severe bleeding, constant suctioning required. Bleeding appears faster than suctioning.

Thoroughout the intraoperative period, the surgeon is free to report a score at any time he/she sees appropriate.

Time Frame throughout surgery, up to 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Tramadol + Metoprolol
Hide Arm/Group Description:
Following an intravenous bolus dose of 0.5 µg/kg remifentanil administered just before the induction of anaesthesia, patients will receive an intravenous infusion of remifentanil at a dose of 0.25-0.5 µg/kg/min throughout the surgery. The rate of infusion will be adjusted to maintain a mean blood pressure within %70-80 of the baseline value. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated.
Just before the induction of anaesthesia, an intravenous infusion of 1 mg/kg of tramadol in 100 ml isotonic fluid will be started. The infusion will be completed in 30 minutes using a perfusor. Additionally, following the administration of the neuromuscular blocking agent, 0.1 mg/kg of intravenous metoprolol will be administered within 5 minutes.
Overall Number of Participants Analyzed 44 44
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
1
(1 to 1)
1
(1 to 1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Tramadol + Metoprolol
Comments Median intraoperative bleeding scores were compared with Wilcoxon test. In this pilot study the power analysis showed that a sample size of 44 patients in each group was sufficient to detect a difference of 0.2 in the mean (standard deviation of 0.4) with an 80% power with an alpha error of 0.05 and a beta error of 20%. The Shapiro-Wilk test was used to test the distribution of data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.69
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Time to Achieve Intraoperative Bleeding Score < 3
Hide Description The intraoperative bleeding score will be reported by the surgeon throughout surgery. At the start of the surgery, a timer will be used to measure the duration to achieve a bleeding score of 2.
Time Frame throughout surgery, up to 20 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Tramadol + Metoprolol
Hide Arm/Group Description:

Following an intravenous bolus dose of 0.5 µg/kg remifentanil administered just before the induction of anaesthesia, patients will receive an intravenous infusion of remifentanil at a dose of 0.25-0.5 µg/kg/min throughout the surgery. The rate of infusion will be adjusted to maintain a mean blood pressure within %70-80 of the baseline value. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated.

Remifentanil: Remifentanil infusion will be started with a bolus dose of 0.5 µg/kg before the induction, and will be continued throughout the surgery at a dose of 0.25-0.5 µg/kg/min. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated.

Just before the induction of anaesthesia, an intravenous infusion of 1 mg/kg of tramadol in 100 ml isotonic fluid will be started. The infusion will be completed in 30 minutes using a perfusor. Additionally, following the administration of the neuromuscular blocking agent, 0.1 mg/kg of intravenous metoprolol will be administered within 5 minutes.

Tramadol: 1 mg/kg tramadol will be added to 100 ml of isotonic fluid, and will be administered intravenously in exactly 30 minutes via a perfusor. The infusion will be started just before the induction.

Metoprolol: 0.1 mg/kg of metoprolol will be administered intravenously within 5 minutes following the administration of neuromuscular blocking agent.

Overall Number of Participants Analyzed 44 44
Mean (Standard Deviation)
Unit of Measure: minutes
8.3  (2.1) 13.4  (4.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Tramadol + Metoprolol
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Bleeding Rate
Hide Description In the end of each surgery, bleeding rate will be calculated as ml/min by dividing total bleeding (amount of blood in the graded suction and sponges minus total irrigation fluid) to the duration of surgery (excluding local anesthetic infiltration, and nasal packing).
Time Frame throughout surgery, up to 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Tramadol + Metoprolol
Hide Arm/Group Description:
Following an intravenous bolus dose of 0.5 µg/kg remifentanil administered just before the induction of anaesthesia, patients will receive an intravenous infusion of remifentanil at a dose of 0.25-0.5 µg/kg/min throughout the surgery. The rate of infusion will be adjusted to maintain a mean blood pressure within %70-80 of the baseline value. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated.
Just before the induction of anaesthesia, an intravenous infusion of 1 mg/kg of tramadol in 100 ml isotonic fluid will be started. The infusion will be completed in 30 minutes using a perfusor. Additionally, following the administration of the neuromuscular blocking agent, 0.1 mg/kg of intravenous metoprolol will be administered within 5 minutes.
Overall Number of Participants Analyzed 44 44
Mean (Standard Deviation)
Unit of Measure: ml/min
0.53  (0.2) 0.45  (0.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Tramadol + Metoprolol
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Postoperative Pain
Hide Description Postoperative pain scores on the day of surgery will be evaluated with a visual analog scale (0: no pain, 10: worst pain ever) at the post anaesthetic care unit (PACU), and the surgical ward. The evaluation will begin after the patient arrives at the post anaesthetic care unit, and will continue for 24 hours.
Time Frame following extubation, up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Tramadol + Metoprolol
Hide Arm/Group Description:
Following an intravenous bolus dose of 0.5 µg/kg remifentanil administered just before the induction of anaesthesia, patients will receive an intravenous infusion of remifentanil at a dose of 0.25-0.5 µg/kg/min throughout the surgery. The rate of infusion will be adjusted to maintain a mean blood pressure within %70-80 of the baseline value. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated.
Just before the induction of anaesthesia, an intravenous infusion of 1 mg/kg of tramadol in 100 ml isotonic fluid will be started. The infusion will be completed in 30 minutes using a perfusor. Additionally, following the administration of the neuromuscular blocking agent, 0.1 mg/kg of intravenous metoprolol will be administered within 5 minutes.
Overall Number of Participants Analyzed 44 44
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
VAS at arrival to PACU
3
(2 to 6)
3
(2 to 3)
VAS at discharge from PACU
4
(3 to 5)
4
(3 to 5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Tramadol + Metoprolol
Comments Null hypothesis was that the visual analog pain scores (VAS) of patients at arrrival to post anesthetic care unit (PACU) were similar.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Remifentanil, Tramadol + Metoprolol
Comments Null hypothesis was that the visual analog pain scores (VAS) of patients at discharge from post anesthetic care unit (PACU) were similar.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With Postoperative Nausea and Vomiting
Hide Description Postoperative nausea, retching, and vomiting on the day of surgery will be evaluated with a four-point ordinal scale (0-none, 1-nausea, 2-retching, 3-vomiting) at the post anaesthetic care unit, and the surgical ward. The evaluation will begin after the patient arrives at the post anaesthetic care unit, and will continue for 24 hours.
Time Frame following extubation, up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Remifentanil Tramadol + Metoprolol
Hide Arm/Group Description:
Following an intravenous bolus dose of 0.5 µg/kg remifentanil administered just before the induction of anaesthesia, patients will receive an intravenous infusion of remifentanil at a dose of 0.25-0.5 µg/kg/min throughout the surgery. The rate of infusion will be adjusted to maintain a mean blood pressure within %70-80 of the baseline value. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated.
Just before the induction of anaesthesia, an intravenous infusion of 1 mg/kg of tramadol in 100 ml isotonic fluid will be started. The infusion will be completed in 30 minutes using a perfusor. Additionally, following the administration of the neuromuscular blocking agent, 0.1 mg/kg of intravenous metoprolol will be administered within 5 minutes.
Overall Number of Participants Analyzed 44 44
Measure Type: Count of Participants
Unit of Measure: Participants
14
  31.8%
10
  22.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remifentanil, Tramadol + Metoprolol
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description Adverse event data were collected during the whole study period.
 
Arm/Group Title Remifentanil Tramadol + Metoprolol
Hide Arm/Group Description Following an intravenous bolus dose of 0.5 µg/kg remifentanil administered just before the induction of anaesthesia, patients will receive an intravenous infusion of remifentanil at a dose of 0.25-0.5 µg/kg/min throughout the surgery. The rate of infusion will be adjusted to maintain a mean blood pressure within %70-80 of the baseline value. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated. Just before the induction of anaesthesia, an intravenous infusion of 1 mg/kg of tramadol in 100 ml isotonic fluid will be started. The infusion will be completed in 30 minutes using a perfusor. Additionally, following the administration of the neuromuscular blocking agent, 0.1 mg/kg of intravenous metoprolol will be administered within 5 minutes.
All-Cause Mortality
Remifentanil Tramadol + Metoprolol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Remifentanil Tramadol + Metoprolol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/44 (47.73%)      0/44 (0.00%)    
Blood and lymphatic system disorders     
Intraoperative bleeding  [1]  0/44 (0.00%)  0 0/44 (0.00%)  0
Cardiac disorders     
Intraoperative hypotension  [2]  3/44 (6.82%)  8 0/44 (0.00%)  0
Intraoperative bradycardia  [3]  18/44 (40.91%)  44 0/44 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Occurrence of intraoperative bleeding serious enough to cause a postponement or cancellation of surgery.
[2]
Occurrence of intraoperative hypotension defined as a drop in mean blood pressure by > 30% from baseline.
[3]
Occurrence of intraoperative bradycardia defined as heart rate below 50 beats per min.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Remifentanil Tramadol + Metoprolol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/44 (0.00%)      0/44 (0.00%)    
Cardiac disorders     
Adverse hemodynamic event in the surgical ward  [1]  0/44 (0.00%)  0 0/44 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Occurrence of any adverse hemodynamic event (hypertensive episode, hypotensive episode, tachycardia, bradycardia).
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Başar Erdivanlı
Organization: Recep Tayyip Erdoğan Üniversitesi
Phone: 04642130491 ext 2128
EMail: berdivanli@gmail.com
Layout table for additonal information
Responsible Party: Başar Erdivanlı, Rize Üniversitesi
ClinicalTrials.gov Identifier: NCT02484859    
Other Study ID Numbers: 2015/14
First Submitted: June 19, 2015
First Posted: June 30, 2015
Results First Submitted: February 16, 2016
Results First Posted: September 10, 2019
Last Update Posted: September 17, 2019